Nctid:
NCT00000695
Payload:
{"FullStudy"=>{"Rank"=>492115, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"April 26, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012514", "ConditionMeshTerm"=>"Sarcoma, Kaposi"}, {"ConditionMeshId"=>"D000012509", "ConditionMeshTerm"=>"Sarcoma"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000018204", "ConditionAncestorTerm"=>"Neoplasms, Connective and Soft Tissue"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000014777", "ConditionAncestorTerm"=>"Virus Diseases"}, {"ConditionAncestorId"=>"D000006566", "ConditionAncestorTerm"=>"Herpesviridae Infections"}, {"ConditionAncestorId"=>"D000004266", "ConditionAncestorTerm"=>"DNA Virus Infections"}, {"ConditionAncestorId"=>"D000009383", "ConditionAncestorTerm"=>"Neoplasms, Vascular Tissue"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15327", "ConditionBrowseLeafName"=>"Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10283", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6368", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18250", "ConditionBrowseLeafName"=>"HIV Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15332", "ConditionBrowseLeafName"=>"Sarcoma, Kaposi", "ConditionBrowseLeafAsFound"=>"Sarcoma, Kaposi", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M3522", "ConditionBrowseLeafName"=>"Acquired Immunodeficiency Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10199", "ConditionBrowseLeafName"=>"Immunologic Deficiency Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M20350", "ConditionBrowseLeafName"=>"Neoplasms, Connective and Soft Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17522", "ConditionBrowseLeafName"=>"Virus Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9643", "ConditionBrowseLeafName"=>"Herpesviridae Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7442", "ConditionBrowseLeafName"=>"DNA Virus Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12328", "ConditionBrowseLeafName"=>"Neoplasms, Vascular Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5284", "ConditionBrowseLeafName"=>"Soft Tissue Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T3199", "ConditionBrowseLeafName"=>"Kaposi Sarcoma", "ConditionBrowseLeafAsFound"=>"Kaposi's Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000007372", "InterventionMeshTerm"=>"Interferons"}, {"InterventionMeshId"=>"D000015215", "InterventionMeshTerm"=>"Zidovudine"}, {"InterventionMeshId"=>"D000016899", "InterventionMeshTerm"=>"Interferon-beta"}, {"InterventionMeshId"=>"D000068576", "InterventionMeshTerm"=>"Interferon beta-1b"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000000998", "InterventionAncestorTerm"=>"Antiviral Agents"}, {"InterventionAncestorId"=>"D000000890", "InterventionAncestorTerm"=>"Anti-Infective Agents"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000018894", "InterventionAncestorTerm"=>"Reverse Transcriptase Inhibitors"}, {"InterventionAncestorId"=>"D000019384", "InterventionAncestorTerm"=>"Nucleic Acid Synthesis Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000019380", "InterventionAncestorTerm"=>"Anti-HIV Agents"}, {"InterventionAncestorId"=>"D000044966", "InterventionAncestorTerm"=>"Anti-Retroviral Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000276", "InterventionAncestorTerm"=>"Adjuvants, Immunologic"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M10407", "InterventionBrowseLeafName"=>"Interferons", "InterventionBrowseLeafAsFound"=>"End", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M19244", "InterventionBrowseLeafName"=>"Interferon-beta", "InterventionBrowseLeafAsFound"=>"A 10-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M275", "InterventionBrowseLeafName"=>"Interferon beta-1b", "InterventionBrowseLeafAsFound"=>"eHealth", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17920", "InterventionBrowseLeafName"=>"Zidovudine", "InterventionBrowseLeafAsFound"=>"Every 4 weeks", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M10405", "InterventionBrowseLeafName"=>"Interferon Type I", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4314", "InterventionBrowseLeafName"=>"Antiviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4214", "InterventionBrowseLeafName"=>"Anti-Infective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M4281", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20935", "InterventionBrowseLeafName"=>"Reverse Transcriptase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7951", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21350", "InterventionBrowseLeafName"=>"Anti-HIV Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25428", "InterventionBrowseLeafName"=>"Anti-Retroviral Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M10201", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3628", "InterventionBrowseLeafName"=>"Adjuvants, Immunologic", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"36"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"October 2021", "CompletionDateStruct"=>{"CompletionDate"=>"July 1991", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"October 26, 2021", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 2, 2021", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Drug Evaluation", "Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "Zidovudine", "Interferon Type I"]}, "ConditionList"=>{"Condition"=>["Sarcoma, Kaposi", "HIV Infections"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferenceType"=>"background", "ReferenceCitation"=>"Stavermann T, Bauer G, Ruess A. Recombinant interferon-beta in the therapy of advanced AIDS-related Kaposi's sarcoma. Int Conf AIDS. 1993 Jun 6-11;9(1):402 (abstract no PO-B12-1600)"}, {"ReferencePMID"=>"9557213", "ReferenceType"=>"background", "ReferenceCitation"=>"Miles S, Levine A, Feldstein M, Carden J, Cabriallas S, Marcus S, Mitsuyasu R, Gill P. Open-label phase I study of combination therapy with zidovudine and interferon-beta in patients with AIDS-related Kaposi's sarcoma: AIDS Clinical Trials Group Protocol 057. Cytokines Cell Mol Ther. 1998 Mar;4(1):17-23."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption.\n\nIFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.", "DetailedDescription"=>"IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants.\n\nPatients undergo evaluations to determine the extent of their disease and the status of their immune system. Patients then receive IFN-B subcutaneously once a day at one of three different dose levels. Patients also take AZT at 1 of 2 doses. The first 12 patients are treated with the lower dose of AZT. The first 4 patients are entered at level 1 of IFN-B. If no dose-limiting toxicity is seen in these 4 patients after 2 weeks of therapy, 4 patients are then enrolled at level 2 of IFN-B. The study proceeds in this manner until the highest tolerated dose or level 3 is reached. If both drugs are tolerated, patients then remain on both medications as long as they continue to tolerate the medications and show some improvement in either antiviral response, immune response, or clinical response for as long as 24 weeks. The initial three doses of IFN-B are given to each patient at the study site during which time the patient is trained to self-administer the IFN-B. Patients are then seen weekly for 4 months and every 2 weeks thereafter."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"12 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Treatment:\n\nAllowed:\n\nLocal radiotherapy or laser therapy to cosmetically apparent Kaposi's lesions, provided the dose to any one lesion does not exceed 3000 gray and the total surface area of all lesions treated does not exceed 10 cm2 during the course of the trial.\n\nPatients must demonstrate the following clinical and laboratory findings:\n\nPositive for HIV by federally licensed ELISA test.\nAcceptable bone marrow function.\nAcceptable renal function.\nAcceptable hepatic function.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\nOther potentially antiretroviral compounds.\n\nPatients will be excluded from the study for the following reasons:\n\nConcurrent, active opportunistic infections requiring therapy.\nExtensive Kaposi's sarcoma with more than 100 cutaneous lesions, requiring systemic chemotherapy, prior treatment with more than one chemotherapy regimen, excluding intralesional therapy, or symptomatic visceral Kaposi's sarcoma.\nEvidence of clinically significant cardiac dysfunction (New York Heart Association grade III or IV).\nHistory of malignant neoplasms other than nonmelanomatous skin cancer or cancer in situ of the cervix.\nProteinuria of 2+ or greater and/or 24-hour urine protein of greater than 1.\n\nPrior Medication:\n\nExcluded:\n\nMore than one chemotherapy regimen for Kaposi's sarcoma.\nAny interferon preparation or zidovudine (AZT).\nExcluded within 30 days of study entry:\nOther immunomodifiers.\nAcyclovir.\nOther investigational drugs.\nExcluded within 60 days of study entry:\nCytotoxic therapy.\n\nPatients may not have any of the following diseases or symptoms:\n\nDevelopment of an AIDS-defining opportunistic infection, other than oral thrush or localized zoster.\nNon-Kaposi's sarcoma, AIDS-defining malignancy."}, "IdentificationModule"=>{"NCTId"=>"NCT00000695", "BriefTitle"=>"Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma", "OrgStudyIdInfo"=>{"OrgStudyId"=>"ACTG 057"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"11031", "SecondaryIdType"=>"Registry Identifier", "SecondaryIdDomain"=>"DAIDS ES Registry Number"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Interferon beta-1b", "InterventionType"=>"Drug"}, {"InterventionName"=>"Zidovudine", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"Los Angeles County - USC Med Ctr"}, {"LocationZip"=>"90033", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"USC School of Medicine / Norris Cancer Hosp"}, {"LocationZip"=>"90095", "LocationCity"=>"Los Angeles", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"UCLA CARE Ctr"}, {"LocationZip"=>"60611", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Northwestern Univ Med School"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"S Miles", "OverallOfficialRole"=>"Study Chair"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
